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Nighttime Losartan in Continous Ambulatory Peritoneal Dialysis (NVCAPD)

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ClinicalTrials.gov Identifier: NCT03692013
Recruitment Status : Not yet recruiting
First Posted : October 2, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University

Study Description
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Brief Summary:
Hypertension is one of the most important independent risk factors for the prognosis of continous ambulatory peritoneal dialysis patients. The incident rate is high and the control rate is low. Nocturnal hypertension has been paid more attention in recent years. Compared to daytime blood pressure, nocturnal blood pressure is an independent and efficient prognostic indicator of hypertensive deaths and cardiovascular events, but it is lack of evidence about its impact on prognosis in peritoneal dialysis patients and the effective treatment program. Our previous cohort study suggests that the incidence of nocturnal hypertension in patients with chronic kidney disease is up to 71.22%, with a significant increase as the decline of renal function, and more severe target organ damage in patients with nocturnal hypertension: the decrease of glomerular filtration rate, left ventricular hypertrophy, and the increase of all cause death and cardiovascular death. Our small sample size study show that night time antihypertensive drugs can better control blood pressure and delay the development of left ventricular hypertrophy. These preliminary results suggest that nocturnal hypertension is closely related to the prognosis of chronic renal disease. Taking antihypertensive drugs at night is one of the options for controlling nocturnal hypertension. However, it is not clear whether taking antihypertensive drugs at night can improve the prognosis of maintenance peritoneal dialysis patients with nocturnal hypertension. To this end, the investigators collect continous ambulatory peritoneal dialysis patients with nocturnal hypertension, and propose a time selective use of losartan to intervene in nocturnal hypertension. By comparing the difference in the effects of losartan on the prognosis of maintenance peritoneal dialysis patients during the day or night, to further clarify the role of nocturnal hypertension in the prognosis of maintenance peritoneal dialysis patients, whether controlling nocturnal hypertension can improve the prognosis of maintenance peritoneal dialysis patients. The completion of study will optimize the prevention and treatment of hypertension in maintenance peritoneal dialysis patients, and provide an evidence for precise prevention and treatment of nocturnal hypertension in maintenance peritoneal dialysis patients.

Condition or disease Intervention/treatment Phase
Hypertension,Nephropathy Drug: Losartan Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Nighttime Losartan on Prognosis of Nocturnal Hypertension Patients Undergoing Continous Ambulatory Peritoneal Dialysis
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
Experimental: nighttime group
patients with nocturnal hypertension taking losartan at nighttime
 Drug: Losartan
Participants will be divided into 2 groups as daytime group and nighttime group The participants in daytime group will take 100-200mg Losartan in the morning between 6AM to 8AM. The participants in nighttime group will take 100-200mg Losartan at night between 9PM to 11PM .
Other Name: Cozaar
Active Comparator: daytime group
patients with nocturnal hypertension taking losartan at daytime
 Drug: Losartan
Participants will be divided into 2 groups as daytime group and nighttime group The participants in daytime group will take 100-200mg Losartan in the morning between 6AM to 8AM. The participants in nighttime group will take 100-200mg Losartan at night between 9PM to 11PM .
Other Name: Cozaar


Outcome Measures
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Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: 5 years ]
    Rate of death caused by all causes


Secondary Outcome Measures :
  1. cardiovascular mortality [ Time Frame: 5 years ]
    Rate of death caused by cardiovascular events, such as myocardial infarction,arrythmia and heart failure

  2. cerebrovascular mortality [ Time Frame: 5 years ]
    Rate of death caused by cerebral vascular events, such as stroke

  3. incidence of cardiocerebral vascular events [ Time Frame: 5 years ]
    Incidence of cardiovascular and cerebrovascular events that require hospitalization and lead to death or non death, including myocardial infarction, heart failure, stroke,vascular reconstruction,peripheral vascular disease, and non-traumatic amputation


Other Outcome Measures:
  1. incidence of cardiovascular structural abnormalities [ Time Frame: 5 years ]
    Incidence changes of carotid artery intima-media thickness and left ventricular mass index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age over 18 years old and <75 years.
  2. Diagnosed as chronic kidney disease 5th stage in accordance with the KDIGO guide 2012 (egfr < 15 ml/ (min 1.73m2)).
  3. Accept 3-5 bags daily, continous ambulatory peritoneal dialysis for >3 months.
  4. Ambulatory blood pressure monitoring indicates nighttime systolic blood pressure (SBP) > 120mmHg and / or diastolic blood pressure (DBP) > 70mmHg.

Exclusion Criteria:

  1. Night learning or work, irregular rest for a long time.
  2. Moderate and severe edema in difficult to correct
  3. Persistent atrial fibrillation.
  4. Severe anemia and severe dystrophy.
  5. Patients with postural hypotension or symptomatic hypotension.
  6. Severe side effects or contraindications of valsartan treatment.
  7. Treatment of corticosteroids or other hormones at present.
  8. Unable to cooperate or unable to tolerate ambulatory blood pressure monitoring.
  9. Ineffective ambulatory blood pressure data.
  10. The clinical data were incomplete during the treatment period; end-point events occurred within 6 months or follow-up time was less than 6 months.
  11. In the first 3 months before admission, there were obvious cardiovascular and cerebrovascular diseases such as coronary syndrome, myocardial infarction or stroke.
  12. There were complications such as vascular disease, infection and bleeding within 1 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692013


Contacts
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Contact: Lin Lin, Doctor 0086 756 2528701 861282392@qq.com

Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Cheng Wang, Director Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-Sen University
More Information
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Publications:

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Responsible Party: Cheng Wang, Director of Nephrology, Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03692013    
Other Study ID Numbers: Losartan
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University:
Nocturnal hypertension,Peritoneal dialysis,Losartan
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action